The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified October 2007 by Medical University of Vienna. Recruitment status was: Active, not recruiting

Sponsor:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00348738

First Posted: July 6, 2006

Last Update Posted: November 2, 2007

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to determine whether an increase of blood haemoglobin levels through the substitution of erythropoietin during radiotherapy treatment of cervix cancer patients results in improvement for disease specific survival, tumor response and local control.

Patients assigned to this group are receiving Erythropoietin medication

Drug: Erythropoietin

Administration of 10.000 I.U Erythropoeitin SQ 3x/week, two weeks prior to radiation therapy until a haemoglobin concentration of >14g/dl, <15g/dl is reached or until the end of the radiation therapy.

No Intervention: 2

control group receiving no treatment

Detailed Description:

Definitive radiotherapy is the treatment of choice for patients with locally advanced cervix cancer. Low pre-therapeutic values of the intratumoral pO2 are associated with significantly worse therapeutic outcome and the blood hemoglobin levels correlate positively with the intratumoral pO2. Successful augmentation of hemoglobin levels by way of transfusion leads to improvement of therapeutic results. Therefore, a pre-therapeutic transfusion therapy is carried out routinely at a number of hospitals; however this therapy is due to its cost and risks limited to patients with an initial hemoglobin level of < 10 g/dl. To avoid transfusions and to increase patients wellbeing, the efficacy and tolerability of erythropoietin was tested, when administered to increase the lowered hemoglobin levels in tumor patients. The question is, whether or not it is possible, to regularly raise the blood hemoglobin levels in patients with carcinoma of the cervix by administering erythropoietin. If a normal (>12 g/dl) or rather an upper-normal (>14 g/dl) hemoglobin level is reached, then the tumor oxygenation and thus also the response to radiation could be positively influenced. The objective of this study is to improve the response and control rates as well as the disease free survival rates in female patients with primary carcinoma of the cervix within the scope of the curative radiation therapy. The test hypothesis is that by administering erythropoietin the hemoglobin levels are increased and through this increase the response of the tumor to radiation therapy will be improved.

Comparison(s): A prospective, randomized, multi-centric group of female patients treated with Erythropoietin is compared to a parallel stratified control group receiving no treatment.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

19 Years to 80 Years (Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

histologically proven cervix cancer (FIGO stage I-IVA)

Age of 19-80 years

initial blood level of hemoglobin <= 14 g/dl

patients who gave their informed consent

Exclusion Criteria:

Karnofsky-Index < 50 %

known intolerance of erythropoietin

FIGO stage IVB

blood transfusion within the last four weeks

neoadjuvant chemotherapy

previous radiation therapy of the abdomen

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348738

Locations

Austria

Department of Radiotherapy-University Hospital of Innsbruck

Innsbruck, Austria, A-6020

Department of Radiotherapy-University Hospital of Salzburg

Salzburg, Austria, A-5020

Department of Radiotherapy and Radiobiology-Medical University of Vienna

Vienna, Austria, A-1090

Department of Radiotherapy-Hospital of Hietzing

Vienna, Austria, A-1130

Sponsors and Collaborators

Medical University of Vienna

Investigators

Study Chair:

Richard Poetter, Prof., M.D.

Department of Radiotherapy and Radiobiology-Medical University of Vienna